Enicepatide for weight management in people with overweight or obesity and type 2 diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a phase 3, randomized, placebo-controlled trial comparing multiple doses of enicepatide, a dual GLP-1/GIP receptor agonist, to placebo for weight management in people with overweight or obesity and type 2 diabetes. Participants must have a BMI ≥27 kg/m2 and HbA1c between 6.5% and 10%, and may be on stable oral diabetes therapy or diet/exercise alone but not on GLP-1 receptor agonists or DPP‑4 inhibitors. The drug is administered by injection and participants must be willing and able to self-administer or receive injections from a trained person. The study will collect efficacy outcomes for weight change and safety data across the enrolled dose groups at participating U.S. clinical sites.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Ability and willingness to self-administer the study drug (or receive an injection from a trained individual if visually impaired or with physical limitations)
* Diagnosis of type 2 diabetes mellitus (T2DM) according to WHO classification or other locally applicable standards with HbA1c ≥6.5% to ≤10% determined by laboratory test at screening, and on stable oral therapy for at least 3 months prior to screening (if applicable). T2DM may be treated with diet/exercise alone or any oral anti-hyperglycemic medication (as per local labeling) EXCEPT dipeptidyl peptidase 4 (DPP-4) inhibitors or GLP-1 RA-based therapy.
* Body mass index (BMI) ≥27.0 kg/m\^2
* History of ≥1 self-reported unsuccessful diet/exercise effort to lose body weight

Exclusion Criteria:

* History of type 1 diabetes mellitus (T1DM) or any lifetime history of ketoacidosis or history of hyperosmolar state/coma within 12 months prior to screening
* Have had 1 or more episodes of severe hypoglycemia and/or has hypoglycemia unawareness within the 6 months prior to screening
* At least 2 confirmed fasting blood glucose values \>270 mg/dL (15.0 mmol/L) (on 2 non-consecutive days) during screening
* Self-reported change in body weight \>5 kg within 3 months prior to screening
* Obesity induced by other endocrinologic disorders (e.g., Cushing's syndrome) or diagnosed monogenetic or syndromic forms of obesity (e.g., melanocortin 4 receptor deficiency or Prader-Willi syndrome)
* Prior or planned surgical treatment for obesity. Liposuction or abdominoplasty if performed more than 1 year prior to screening is allowed.
* Known clinically significant gastric emptying abnormality (e.g., severe gastroparesis or gastric outlet obstruction)
* Poorly controlled hypertension at screening
* Have any of the following cardiovascular conditions within 3 months prior to screening: Acute myocardial infarction; Cerebrovascular accident (stroke)/transient ischemic attack; Unstable angina; Hospitalization due to congestive heart failure
* Treatment with any approved or investigational GLP-1-RA-based therapy (e.g., GLP-1 receptor mono agonist, GLP-1/GIP receptor dual agonist, GLP-1/GIP/Gluc receptor triple agonist) within 6 months prior to randomization

Where it's running

• Lakeview Clinical Research
  Guntersville, Alabama, United States Recruiting
• Arizona Clinical Trials
  Tucson, Arizona, United States Recruiting
• University of California Irvine
  Irvine, California, United States Recruiting
• Orange County Research Center
  Lake Forest, California, United States Recruiting
• Ark Clinical Research
  Long Beach, California, United States Recruiting
• Catalina Research Institute, LLC
  Montclair, California, United States Recruiting

+172 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Reference Study ID Number: WC45726 https://forpatients.roche.com/ No attachments to email below.
• Email: global-roche-genentech-trials@gene.com
• Phone: 888-662-6728 (U.S. Only)

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.